J Am Coll Cardiol. 2026 Jun 24:S0735-1097(26)06637-4. doi: 10.1016/j.jacc.2026.05.025. Online ahead of print.
ABSTRACT
BACKGROUND: Patients with diabetes frequently have multivessel disease and are at increased risk of adverse outcomes. The outcomes with a new-generation ultra-thin strut sirolimus-eluting stent (SES) vs everolimus-eluting stent (EES) is unclear as stent-to-stent comparison trials have routinely excluded these patients or included a small proportion of such patients.
OBJECTIVES: The purpose of this study was to compare the clinical outcomes of ultra-thin biodegradable polymer (BP) SES vs durable polymer (DP) EES when combined with contemporary optimal medical therapy in patients with diabetes and multivessel disease.
METHODS: The TUXEDO-2 is an investigator-initiated prospective, open-label, multicenter, 2 × 2 factorial, randomized (1:1) controlled trial. Patients undergoing percutaneous coronary intervention were randomized to receive either a Supraflex Cruz SES or Xience EES. The participants were also randomized to Ticagrelor or Prasugrel. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 1-year follow up. The trial was designed to test noninferiority of BP-SES vs DP-EES, with a noninferiority margin of 4.5% (1-sided upper 97.5% confidence bound).
RESULTS: Among the 1,800 patients randomized, mean age was 60.3 years with 28% of participants being women. At 1 year, the primary endpoint of target lesion failure occurred in 148 patients, including 70 patients (7.92%) in the BP-SES group and 78 patients (8.75%) in the DP-EES group. The risk difference of -0.83 percentage points (1-sided upper 97.5% confidence bound 3.42%) met the prespecified noninferiority margin (P = 0.005). There were no significant differences in cardiac death (3.6% vs 3.4%), target vessel myocardial infarction (6.61% vs 7.54%), and ischemia-driven target lesion revascularization (0.8% vs 1.0%) between the 2 groups. Nonfatal myocardial infarction (4.7% vs 6.4%) and stent thrombosis was similar (1.0 % vs 0.7%) between the 2 groups.
CONCLUSIONS: In patients with diabetes and multivessel disease undergoing percutaneous coronary intervention, ultra-thin biodegradable polymer SES was noninferior to durable polymer EES at 1 year follow-up. (Trial Registration Number CTRI/2019/11/022088).
PMID:42383943 | DOI:10.1016/j.jacc.2026.05.025